PRODIGE 24 — Modified FOLFIRINOX Versus Gemcitabine as Adjuvant Therapy for Resected Pancreatic Cancer

Phase 3 · 2018 · Pancreatic Cancer

Design

Randomized adjuvant trial comparing modified FOLFIRINOX versus gemcitabine after macroscopically complete pancreatic resection.

Population

Patients with resected pancreatic ductal adenocarcinoma, ECOG 0-1, and normalized post-op CA 19-9.

Primary Endpoint

disease-free survival (DFS)

Key Result

Median DFS 21.6 vs 12.8 months (HR 0.58); median OS 54.4 vs 35.0 months (HR 0.64).

Guideline Impact

NCCN category 1 adjuvant regimen for resected pancreatic cancer (good PS)